California Newborn Screening Program

Specimen Collection Procedure

The Specimen Collection Form or Test request Form (TRF) for Newborn Screening is provided to every perinatal licensed health facility by the Genetic Disease Screening Program (GDSP) at a cost of $1.00 per form. GDSP also bills the facility a program fee of $111.70 for each completed specimen received. The facilities in turn can charge $1.00 plus the program fee per newborn for the total screening process. (This includes the initial test and any necessary repeat or recall testing until the newborn screen is resolved.) In addition, each facility may charge up to $6.00 for specimen collection and handling. Medi-Cal covers the complete screening process, including the specimen collection fee. Private insurance generally covers both the newborn screening and the specimen collection fee.

The TRF is the only acceptable form for newborn screening tests. The TRF consists of a filter paper card for specimen collection and a page containing fields for recording critical information about the baby. It also contains information about screening on pages that are to be detached and given to the mother.

The completed TRF is sent to the designated State-contracted newborn screening and prenatal (NAPS) laboratories for data entry and testing of the dried blood spots (DBS). All information, including the test results, are transmitted via computer to a central site in Richmond, CA, from which follow-up is monitored and result mailers are sent. The coordination of follow-up of non-negative screens, i.e., inadequate specimens, specimens collected too early and initial positive tests, is conducted at NBS Area Service Centers.

DRIED BLOOD SPOT (DBS) COLLECTION

Instructions for collecting adequate dried blood spots appear on the Test Request Form

Example: LOT XXXXXX/XXXXX2015-02 (the expiration year is 2015, and the expiration month is 02) - do not use as of the FIRST DAY of the expiration month.

A specimen collected on an expired form will be deemed inadequate and the screen will need to be redone, thus delaying test results.

2. AVOID TOUCHING THE SPECIMEN COLLECTING AREA at any time with gloved or ungloved hands. Oil, lotion, or powder from hands or gloves can prevent the blood from spreading evenly and thoroughly. Use un-powdered gloves.

3. BLOOD IS TO BE COLLECTED FROM THE HEEL. Do NOT collect blood from intravenous/intra-arterial lines, antecubital space or dorsal hand veins unless a heel stick is not possible.

4. DO NOT USE CAPILLARY TUBES for collecting the blood to spot on the card. It can damage the filter paper, resulting in an inadequate specimen.

5. STERILIZE the skin with alcohol. WIPE DRY with a sterile gauze pad.

12. SEND SPECIMENS TO THE ASSIGNED NAPS LAB WITHIN 24 HOURS OF COLLECTION. Specimens are transported either by a lab courier or by Golden State Overnight (GSO). A transport log (provided by the NAPS Lab), listing the babies whose specimens are in the envelope, must accompany each shipment.

Reminder: A detached white copy will be viewed as inadequate. If the white copy gets detached, write the baby's name and date of birth on the lines provided on the filter paper, and staple the filter paper to the bottom of the white copy. Collecting the specimen properly and keepng the form intact are crucial the keeping the specimen adequate. An inadequate specimen will need to be redone, and may put the baby in life-threatening danger.

On weekends and holidays, when specimens are not picked up, they should be stored in a controlled environment away from heat and humidity until they can be transported. They should not be refrigerated.

Check with the mail room personnel as to how they assure timely specimen pickup. It is important to avoid exposure to heat and humidity, so if curbside mail collection boxes are used, care needs to be taken as to when these NBS specimen packages are deposited, particularly during the summer months.